Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

Not Applicable

Completed

• Conditions: Bronchiolitis Obliterans; Organizing Pneumonia; Bone Marrow Transplant Infection; Chronic Respiratory Insufficiency; Pulmonary Cytolytic Thrombi
• Interventions: Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

• Registration Number: NCT02032381
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

Detailed Description

It's a multicenter prospective study in France. All children under 18 years are included, just before the HSCT. The functional test before the HSCT at 6, 12, 18, 24, 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT. Thoracic tomodensitometry is done before the HCT and after at 6, 12, 24 and 36 months.

All data will be collected upon the HSCT, the infections before and after the HSCT, the respiratory symptoms, and the treatment. Bronchia alveolar lavage and serum will be collected and frozen during the study.

The inclusion will be done during two years and children will be following during three years.

The purpose is to evaluate the prevalence, the course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

Study Timeline

• Study First Submitted: 2013-12-09
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-10
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age: from birth to 18 years
• Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study
• Affiliation to a social security scheme

Exclusion Criteria

• non exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
allogeneic hematopoietic stem cell	late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.	The eligible population for this study will consist of all children under 18 years who received allogeneic hematopoietic stem cell and evaluate of late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

Primary Outcome Measures

Name	Time	Method
Presence of belated non-infectious pulmonary complications	3 years

Secondary Outcome Measures

Name	Time	Method
Presence of risk factors for belated non-infectious pulmonary complications	3 years
Severity of respiratory disease	3 years
Survival three years	3 years

Trial Locations

Locations (1)

Houdouin véronique; 🇫🇷 Paris, France